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International Conference on Harmonisation; Draft Guidance on Q9 Quality Risk Management; Availability

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Q9 Quality Risk Management.” The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The draft guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.

DATES:

Submit written or electronic comments on the draft guidance by October 7, 2005. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The draft guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: David J. Horowitz, Center for Drug Evaluation and Research (HFD-300), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8910; Anna M. Flynn, Center for Biologics Evaluation and Research (HFM-610), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6201; Diana J. Kolaitis, Office of Regulatory Affairs (HFR-NE1), Food and Drug Administration, Start Printed Page 45723158-15 Liberty Ave., Jamaica, NY 11433, 718-662-5416; or H. Gregg Claycamp, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-4354.

Regarding the ICH: Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480.

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SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

During the July 2003 ICH meeting in Brussels, agreement was reached on a common vision and approach for developing an international plan for a harmonized pharmaceutical quality system that would be applicable across the lifecycle of a product. This plan emphasizes an integrated approach to review (assessment) and inspection based on scientific risk management. One aspect of the plan was the establishment of an expert working group to develop guidance for quality risk management.

In March 2005, the ICH Steering Committee agreed that a draft guidance entitled “Q9 Quality Risk Management” should be made available for public comment. The draft guidance is the product of the Quality Risk Management Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the ICH expert working group.

The draft guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. These quality risk management approaches apply to the development, manufacturing, distribution, inspection, and submission/review processes, including the use of raw materials, solvents, excipients, and packaging and labeling materials. The draft guidance is intended to support other ICH quality documents, to complement existing quality practices and standards, and to enable regulators and industry to make more effective and consistent risk-based decisions.

This document supports FDA's “Pharmaceutical Current Good Manufacturing Practices for the 21st Century” initiative, which was intended to bring a 21st century focus to the regulation of pharmaceutical manufacturing and product quality. One objective of this initiative is to encourage the implementation of risk-based approaches that focus both industry and agency attention on critical areas.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on Q9 quality risk management. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​ohrms/​dockets/​default.htm, http://www.fda.gov/​cder/​guidance/​index.htm, or http://www.fda.gov/​cber/​reading.htm.

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Dated: August 1, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 05-15546 Filed 8-5-05; 8:45 am]

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